Manufacturing Science Technology & Project Manager FDF products

Barcelona Permanente

Actualizado el 01/06/2022

  • Tech Transfer, scalability, validation, compliance, regulatory, manufacturing
  • Finished Dosage Forms (FDF) & CMOs

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API Multinational Company

Descripción

MST & Project Manager, ESO Owns technical stewardship of FDF products (E2E oversight of manufacturing process & technology, specifications, validation & continuous improvement), support regulatory with filing/maintenance questions, QA support with troubleshooting customer/supplier matters all in coordination with CDMO/CRO's and other company departments. Owns & leads technology transfers as part of network optimization/portfolio expansion plans and responsible for project team.

The main activities and responsibilities

  • General: Represent the technology function in ESO with coordination across the company and 3rd parties. Build and maintain an adequate external network to deliver on customer commitments and long-term growth plans. Acts as SPoC & SME across the company on all product, process & technology related matters in compliance with industry regulatory/quality guidelines.
  • Operational: accountable for ensuring the portfolio is maintained in a validated/compliant status across the product lifecycle. Develops portfolio risk assessment and implements annual continuous improvement plans for marketed portfolio. Technical coordination/support with CDMO/CRO & Centrient departments across product, process, specification & technology, related to Regulatory maintenance/new filings, Quality action points/troubleshooting and root-cause/CAPA of production issues.
  • Tech transfer & network due- diligence: Project lead for assigned dossier/tech transfers across FDF manufacturing network. Accountable for delivering against business case mandate across the entire project scope (e.g. technical protocol development, AMT, engineering batches, scale-up/validation & dossier submission). Responsible for coordinating a cross-functional project team, their deliverables and reporting status through governance. Responsible for providing technical due-diligence support on portfolio/asset acquisitions and evaluation of new to network CRO/CDMO's.
  • Shared responsibility in cross-functional Teams within ESO & FDF organization
  • Give Technology support to own FDF Development Team and other disciplines, company-wide within the company
  • General compliance
  • Being responsible for budget/cost, timeline, and risk management of assigned technical projects

Perfil Buscado (H/M/D)

  • At least 6 years of experience in Pharmaceutical Technology, preferably in Generics.
  • Academic degree (MSc) in Technology, Pharmacy, Biochemistry or related field. Advanced degree preferred.
  • Broad, multidisciplinary experience.
  • Professional English level (company official language)
  • Well-trained in all relevant Quality and SHE policies and procedures.
  • Managerial and social knowledge and experience.
  • Having extensive experience in pharmaceutical production (Test to Pilot to Full-scale).
  • Having experience in analytical chemistry.
  • Having extensive experience in collaborations with (international) third parties.
  • Having experience in bringing generics to the Market.
  • Customer and external focus.
  • Drive for results.
  • Improve, Innovate and Change.
  • Engage People.
  • Act Responsibly.
  • Passion for success and driving results
  • Improve, Innovate and Change
  • Flexible, agile, proactive with a "never give up" type of mindset
  • Customer and external focus
  • Structured, Analytical, Creative
  • Collaborating cross-functional, both internally and with 3rd parties, Engage People

Qué ofrecemos

  • Multinational environment
  • Fix contract
  • Barcelona based but open for international home office
  • Great salary package
Ver más ofertas de empleo
Cristian Atik
Indicar número de referencia para la oferta
JN-042022-5586237

Resumen de empleo

Sector
Ingenieros
Sub Sector
Gestión de Proyectos
Industria
Healthcare / Pharmaceutical
Localización
Barcelona
Tipo de Contracto
Permanent
Nombre del consultor
Cristian Atik
Número de referencia
JN-042022-5586237

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